FDA Warns of Cancer Risk With Laparoscopic Device

WASHINGTON -- Hysterectomy and procedures to remove uterine fibroids should avoid use of laparoscopic power morcellation, according to a safety advisory from the Food and Drug Administration.

Concluding that the devices pose "a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas," the FDA discouraged use of power morcellators in association with hysterectomy or myomectomy.

A review of data suggested unintentional spread of cancer cells occurs in one of every 350 procedures involving power morcellation. No reliable means exists to determine in advance whether a uterine fibroid harbors cancer.

"If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly reducing the patient's likelihood of long-term survival," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said during a press briefing.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids has uterine sarcoma, the FDA discourages use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

Maisel said FDA has received about a dozen reports of cancer spread related to laparoscopic power morcellation, but he acknowledged that the reporting system tends to underestimate rates of adverse events.

Of the 500,000+ hysterectomies performed in the U.S. each year, about 40% involve treatment of uterine fibroids, he said, and about 50,000 of the procedures are performed laparoscopically.

When feasible, vaginal hysterectomy leads to similar or better results with a lower risk of complications as compared with laparoscopic or abdominal hysterectomy, he added.

The safety advisory does not remove power morcellators from the market. Maisel said the decision to use a power morcellator during hysterectomy or myomectomy should be made by the patient and her doctor after a thorough discussion of the risks and benefits.

In the meantime, FDA offered four recommendations to healthcare professionals about information on laparoscopic power morcellators:

The agency discourages use of the devices during treatment for uterine fibroids.

Do not use laparoscopic power morcellators in women with suspected or known uterine cancer.

Consider all treatment options available for women with symptomatic uterine fibroids.

Discuss with patients the risks and benefits of all treatments.

If a healthcare professional concludes that laparoscopic power morcellation is the best option for a patient, the provider should inform patients about the potential to spread undiagnosed cancer cells. Providers also should be aware that some authorities advocate use of a specimen bag during morcellation to contain tissue and reduce the risk of cancer spread.

In response to the FDA advisory, the American College of Obstetricians and Gynecologists (ACOG) issued a statement noting that the organization is conducting its own review of the evidence on power morcellation and the risk of spreading cancer.

"We greatly appreciate the urgency behind this issue," ACOG officials said in the statement.

The FDA will continue to examine the risks and benefits of power morcellation at an as-yet unscheduled public meeting of the agency's Obstetrics and Gynecological Medical Devices Panel. The discussions will likely include the possibility of adding a boxed warning about the cancer risk to labeling for the devices, according to Maisel.

In addition to the safety advisory from the FDA, the Society of Gynecologic Oncology has adopted a position statement, urging clinicians and their patients to have a thorough discussion of the risks and benefits of power morcellation before reaching a decision to use the procedure.

Authors of a recent review of intracorporeal morcellation found 13 cases of unexpected uterine sarcoma in 5,666 procedures performed from 1983 through 2010. Two of the cases involved use of power morcellation, and both patients developed disseminated uterine sarcoma, as reported in JAMA.

"This limited experience is insufficient to estimate harm from this procedure and whether the benefit-to-harm balance is any different from other accepted medical procedures," concluded Kimberly A. Kho, MD, of the University of Texas Southwestern Medical Center in Dallas, and Ceana H. Nezhat, MD, of the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine.

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